Actively Recruiting
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation
Led by National and Kapodistrian University of Athens · Updated on 2026-04-09
16
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating metabolic changes in spine lesions treated with a combination of augmentation and radiofrequency ablation (RFA) in patients with secondary vertebral bone tumors. This pilot study aims to demonstrate the effectiveness of a new percutaneous ablation device called Osteocool-Medtronic while avoiding bias from other treatments. The study focuses on patients with osteolytic or mixed (lytic and sclerotic) spine tumors that are metabolically active. Participants will receive treatment with percutaneous tumor ablation of spine lesions followed by polymer augmentation using the Osteocool-Medtronic device. Only patients with one to three active lesions identified by recent PET-CT scans will be included. After treatment, patients will undergo a follow-up PET-CT to assess the activity at the treated sites. During the study, patients will be informed and asked to consent before treatment. They will have PET-CT scans before and after the procedure to measure metabolic activity changes. The primary outcome is the PET-CT SUV measurement within 24 hours post-treatment. Secondary outcomes include assessments using the Greek Brief Pain Index at 1, 6, and 12 months. The study runs through the end of 2028 and involves monitoring patients’ lesion activity and pain levels over time.
CONDITIONS
Brief Title
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors
- Presence of one to three active spine lesions
- Lesions must be metabolically active on PET-CT performed within the last month
- Patients must provide informed consent
- Willingness to undergo post-treatment PET-CT to assess lesion activity
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo percutaneous tumor ablation of spine lesions followed by polymer augmentation using a medical device.
1 procedure visit (in-person)
Duration - Within 24 hours post-treatment
Participants receive a PET-CT scan after treatment to assess metabolic activity at the treated site.
1 imaging visit (in-person)
Duration - 12 months
Participants are followed up to monitor pain and lesion activity over time.
3 follow-up visits at 1, 6, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
3rd Department of Radiology, NKUOA, General Hospital "LAIKON"
Athens, Athens, Greece, 11527
Actively Recruiting
Research Team
A
Alexis Kelekis, MD PHD, EBIR
M
MARIA IOANNIDI, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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